FDA.reportPublic FDA data

ROCHE DIAGNOSTICS GMBH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96101263002806559ROCHE DIAGNOSTICS GMBH1N2027-01-01SANDHOFER STRASSE 116 MANNHEIM Baden-Wurttemberg DE D-68305

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
188551940353175P990056ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSETMTF2000-11-22
188551781880595P990012ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAGLOM2001-06-01
188551924402293P920031EMIT 2000 CYCLOSPORINE SPECIFIC ASSAYMKW1996-10-02
188551390026319P200014cobas® EZH2 Mutation TestOWD2020-06-18
188551124470200P190034Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheckSEI2021-02-23
188551022409261P190005Elecsys Anti-HBe, PreciControl Anti-HBeSEI2021-02-03
188551570794295P160041COBAS CMVPAB2017-06-01
188551483287736P160019Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg IILOM2016-12-23
188551396788287P150015COBAS HCV TESTMZP2015-10-14
188551359806188P150014COBAS HBV TESTMKT2015-10-14
188551755518183P140021ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCVMZO2015-06-11
188551859715560P130015ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAGLOM2014-03-14
188551401963460P110022ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGMSEI2011-10-26
188551328295118P110020COBAS 4800 BRAF V600 MUTATION TESTOWD2011-08-17
188551719107423P100032ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZERSEI2011-06-27
188552051261422P100031ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBCSEI2011-06-22
188552012092563P100020COBAS HPV TESTMAQ2011-04-19
188551976047152P090008ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZERMZO2010-04-29
188551356533795P050028COBAS TAQMAN HBV TESTMKT2008-09-04
188551525576692P010054ELECSYS ANTI-HBSSEI2002-02-28
188551756106859P000027ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECKLTJ2000-12-12
188551082532934P000012COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0MZP2001-07-03
188551440599428K993706ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAYJMM2000-07-24
188551926115686K992680ELECSYS PARATHYROID HORMONE TEST SYSTEMCEW1999-09-28
188551155420131K991597COBAS INTEGRA AMIKACIN MABLGJ1999-07-22
188551291335869K984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORJIX1999-01-20
188551876226904K984326ELECYS IGE ASSAYJHR1999-02-08
188551622473888K983503ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347CEO1998-12-01
188551618973326K983416ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353JGJ1998-10-21
188551708186577K983176ELECSYS MYOGLOBIN STAT ASSAYDDR1998-09-24
188551954275373K982471B2-MICROGLOBULIN CONTROL SET SERUMJJX1998-08-06
188551273024462K982382COBAS INTEGRA REAGENT CASSETTESCFN1998-09-28
188551873204375K982087ROCHE CRP T CONTROL NDCK1998-08-18
188551102660125K981897ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAECJE1998-08-26
188551445264827K981883ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844CIG1998-07-07
188551627242825K981401BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLSJJY1998-05-18
188551382141846K981282ELECSYS AFPLOJ1998-05-01
188551105672632K980887ELECSYS CEA ON THE ELECSYS 1010DHX1998-06-29
188551775910541K980724TINAQUANT B 2-MICROGLOBULIN ASSAYJZG1998-10-16
188551144412010K973358MYOGLOBIN CONTROL SETJJX1997-10-06
188551037512801K973112ELECSYS DIGOXINKXT1997-10-10
188551322151584K972673AVL 9181 ELECTROLYTE ANALYZERJFP1997-08-20
188551398964521K972639TINA-QUANT HAPTOGLOBINDAD1998-01-09
188551175918744K972638TINA-QUANT PREALBUMINJZJ1998-01-09
188551915856628K972250ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTSJFJ1997-08-12
188551613845861K972235PRECICONTROL TUMOR MARKER 1 AND 2JJY1997-08-12
188551894050329K972135MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SETFPA1997-08-26
188551653675942K971833ELECSYS FERRITINJMG1997-06-02
188551293022210K970459ELECSYS CALCHECK CEAJJX1997-03-06
188551762859187K970458ELECSYS CALCHECK PSAJJX1997-03-06
188551027281253K970146ELECSYS CALCHECK TESTOSTERONEJJX1997-01-30
188551696309166K964841ELECSYS PROGESTERONE ASSAYJLS1997-03-24
188551978491016K964829ELECSYS CALCHECK FSHJIX1996-12-16
188551271898053K964748ELECSYS PROLACTIN ASSAYCFT1997-01-21
188551170251560K964694ELECSYS LH ASSAYCEP1997-01-24
188551681104968K964693ELECSYS FSH ASSAYCGJ1996-12-16
188551919436657K964670ROCHE COBAS-FP REAGENTS FOR TOBRAMYCINLFW1997-02-04
188551743042197K964457ROCHE COBAS IBTEGRA REAGENT CASSETTESJQB1997-01-13
188551346544112K964368ELECSYS CEA ASSAYJIT1997-06-16
188551625787465K963627(MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULEJGS1996-10-24
188551220327566K963213BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROLLBS1996-10-23
188551982306013K963181ELECSYS CALCHECK T UPDATEJJX1996-09-10
188551831794693K963164ELECSYS CALCHECK FT4JJX1996-08-27
188551881027357K963163ELECSYS CALCHECK FT3JJX1996-08-27
188551358231251K963127ELECSYS FT3CDP1996-12-16
188551778654278K962573ELECSYS PRECICONTROL TSHJJX1996-07-22
188551513648163K962508ELECSYS T3CDP1996-08-15
188551386192622K961824COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXINDCF1996-07-23
188551856936213K961500ELECSYS TROPONIN TMMI1996-06-11
188551555233966K961491ELECSYS TSH ASSAYJLW1996-07-22
188551069581016K961490ELECSYS T4 ASSAYCDX1996-06-13
188551707001337K961489ELECSYS FT4 ASSAYCEC1996-06-11
188551591746935K961488ELECSYS T-UPTAKE ASSAYKHQ1996-06-12
188551561525136K961481ELECSYS 2010 ANALYZERJJE1996-06-14
188551965448203K961458AVL 9180 ELECTROLYTE ANALYZERJFP1996-06-12
188551499863019K954992ROCHE COBAS INTEGRA REAGENT CASSETTESCIT1996-01-25
188551676853329K954346CHEMSTRIP MICRAL URINE TEST STRIPSJIR1995-10-26
188551423886760K953239BOEHRINGER MANNHEIM/HITACHI 917 ANALYZERJJE1995-09-25
188551554518933K952839BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAYDML1995-08-24
188551448151041K951595ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTESCGX1995-09-08
188551996325077K945523COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORSLCQ1995-03-09
188551106916597K945187ROCHE ABUSCREEN ONLINE FOR METHAQUALONEKXS1995-04-05
188551751808601K941837ROCHE REAGENT FOR CREATININECGX1994-08-26
188551699741155K934070TINA-QUANT HEMOGLOBIN A1CLCP1994-10-11
188551307103240K932753ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLSDKB1993-07-22
188551884891903K922762ROCHE REAGENT FOR URIC ACID--MODIFICATIONKNK1992-07-09
188551460438044K913614FRUCTOSAMINE ABG21 TEST SYSTEMLCP1991-12-02
188551259472873K897071ROCHE STANDARDS FOR THE COBAS ISE MODULEJIX1990-03-09
188551256823013K896454CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPSJIL1990-01-11
188552029447786K896230COBAS READY TOTAL PROTEIN REAGENTCEK1990-02-16
188551350941039K895666BUN (KINETIC)CDQ1989-10-27
188551335019368K874230PRECINORM LJJY1987-11-23
188551611009721K873049TRIGLYCERIDES GPO WITHOUT FREE GLYCEROLCDT1987-08-28
188551515978118K852318COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORSLFT1985-06-25
188551614815556K844426ALBUMIN BCPCJW1985-01-07
188551642765080K823213DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMICJE1982-11-22
188551513695173K812095ENXYMATIC CREATININE TESTJFY1981-08-31
188551486348780K790335HYCEL MJJF1979-02-27
188551655107532K261686Elecsys Phospho-Tau (217P) PlasmaSET2026-08-19
188551785821371K260049Elecsys Anti-HBc IgMSEI2026-04-07
188551452269052K260048Elecsys Anti-HAV IgMLOL2026-04-07
188551201300482K260046Elecsys Anti-HBc IISEI2026-04-07
188551033492047K260026Tina-quant Cardiac high sensitivity CRP IIINQD2026-04-02
188551494118075K253839Elecsys Anti-SARS-CoV-2QVP2025-12-17
188552015558615K253188CoaguChek XS Plus SystemGJS2025-10-24
188551380529979K252431Elecsys CalcitoninJKR2026-04-24
188551997339352K252280Elecsys Anti-SARS-CoV-2 SQVP2026-04-13
188551333512074K252163Elecsys Phospho-Tau (181P) PlasmaSET2025-10-08
188551610411528K250768Elecsys Anti-SARS-CoV-2QVP2025-06-10
188551799182815K242505Elecsys Cortisol IIIJFT2025-07-17
188551000139075K241453Elecsys sFlt-1 and Elecsys PlGFQWH2025-02-07
188551511044439K241220Tina-quant Lipoprotein(a) Gen.2 MolarityDFC2025-01-24
188551261881002K240197cobas® liat CT/NG/MG nucleic acid testQEP2025-01-16
188551815783476K233454ONLINE TDM MethotrexateLAO2024-02-20
188551405728212K231927Elecsys PTH , Elecsys PTH STATCEW2024-03-22
188552016342030K231348Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSFQSE2023-06-05
188551492474166K230161ONLINE TDM Phenytoin - Free Phenytoin applicationMOJ2023-03-30
188551718557994K223637Elecsys proBNP II, Elecsys proBNP II STATNBC2023-07-21
188551757432607K222610Elecsys Anti-TgJZO2023-09-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JJX462017-04-04
JIT142015-10-02
JIX132013-11-26
JJY122011-07-08
GJS92025-10-24
LOM72016-12-23
JZO52023-09-15
MMI52021-09-21
DKB52014-11-25
CIG52013-07-17
LOL42026-04-07
NBC42023-07-21
LFZ42022-10-12
JIL42019-05-07
DDG42018-11-05
MOI42018-06-22
CJE42017-05-10
NBW42013-03-15
LCP42011-01-20
JIS42001-01-25
QVP32026-04-13
DFC32025-01-24
CEW32024-03-22
CEC32023-04-07
MZO32023-01-04
CDZ32022-05-06
MRG32021-09-01
DHA32021-08-18
PDJ32020-03-26
DCN32020-02-21
OCC32020-02-10
JLW32019-04-16
DJR32017-06-26
CGN32014-10-17
DCF32010-09-10
DDR32009-10-16
DHR32003-09-10
SET22026-08-19
JKR22026-04-24
SEI22026-04-07

PMA#

PMN#

GUDID#

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